biocompatibility standards

Biocompatibility standards ensure that medical devices and materials are safe when used in or on the body. They evaluate whether a product can perform its intended function without causing harmful reactions, such as allergies, toxicity, or infections. These standards involve rigorous testing and assessments, often guided by organizations like ISO and ASTM, to confirm that the materials won’t interfere with bodily tissues or fluids. Essentially, biocompatibility standards help protect patients by ensuring medical products are safe, compatible, and effective for their specific medical applications.